FDA Adverse Event
Summary report: N
*
MDR report key: 2854940
·
Received November 16, 2012
Report
- Report Number
- 2854940
- Date Received
- November 16, 2012
- Date of Event
- July 12, 2011
- Report Date
- November 14, 2012
- Manufacturer
- BIRD & CRONIN
- Product Code
- IQI
- Report Source
- User Facility report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PATIENT HAD A TRAUMATIC NONDISPLACED LEFT PROXIMAL FIBULAR FRACTURE AND A KNEE IMMOBILIZER WAS PLACED ON THE PATIENT'S LEFT LEG DURING SURGERY. EIGHT DAYS LATER, THREE AREAS OF SUSPECTED DEEP TISSUE INJURIES WERE FOUND ON THE BACK OF THE PATIENT'S LEFT LOWER LEG. THE METAL STAYS IN THE IMMOBILIZER CAUSED PRESSURE TO THE AREAS OF THE ULCERS. A LONGER IMMOBILIZER WAS ORDERED AND PLACED AFTER THE POSTERIOR METAL STAYS WERE REMOVED AND PADDING PUT IN PLACE. WOUND OSTOMY CARE NURSE CONSULTED. DEMONSTRATED PROGRESSIVE HEALING OF PRESSURE ULCERS AT TIME OF DISCHARGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | BRACE, EXTERNAL | IQI | BIRD & CRONIN | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |